NDC 0054-0339 Doxercalciferol

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
0054-0339
Proprietary Name:
Doxercalciferol
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Code:
0054
FDA Application Number: [6]
ANDA091433
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
02-18-2014
Listing Expiration Date: [11]
12-31-2021
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
ORANGE (C48331)
PINK (C48328)
YELLOW (C48330)
Shape:
OVAL (C48345)
Size(s):
9 MM
Imprint(s):
R
Score:
1

Code Structure Chart

Product Details

What is NDC 0054-0339?

The NDC code 0054-0339 is assigned by the FDA to the product Doxercalciferol which is product labeled by West-ward Pharmaceuticals Corp.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 0054-0339-19 50 capsule in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Doxercalciferol?

This medication is used to treat people with serious kidney disease on dialysis who have high levels of a certain substance (parathyroid hormone-PTH), which your body normally makes. High PTH levels affect the balance of other minerals in your body (calcium and phosphorus) and may cause weak bones. Doxercalciferol is a form of vitamin D. It works by decreasing PTH levels and increasing calcium/phosphorus levels in the body.

Which are Doxercalciferol UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Doxercalciferol Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Doxercalciferol?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

* Please review the disclaimer below.

Patient Education

Doxercalciferol


Doxercalciferol is used to treat secondary hyperparathyroidism (a condition in which the body produces too much parathyroid hormone [PTH; a natural substance needed to control the amount of calcium in the blood]) in certain people with chronic kidney disease and in those treated with dialysis (medical treatment to clean the blood when the kidneys are not working properly). Doxercalciferol is in a class of medications called vitamin D analogs. It works by helping the body to use more of the calcium found in foods or supplements and by regulating the body's production of parathyroid hormone.
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* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".